Study of CGC-11047 in Patients With Metastatic Hormone Refractory Prostate Cancer

This study has been terminated.

(Further evaluation of phase I dosing)

Sponsor:

Collaborator:

Progen Pharmaceuticals

Information provided by:

University of Wisconsin, Madison

ClinicalTrials.gov Identifier:

NCT00585416

First received: December 21, 2007

Last updated: April 13, 2009

Last verified: April 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	December 21, 2007
Last Updated Date	April 13, 2009
Start Date ^ICMJE	June 2006
Primary Completion Date	November 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 21, 2007)	Efficacy [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00585416 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 21, 2007)	Safety [ Time Frame: Throughout and for 28 days post drug ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study of CGC-11047 in Patients With Metastatic Hormone Refractory Prostate Cancer
Official Title ^ICMJE	A Phase II Study of CGC-11047 in Patients With Metastatic Hormone Refractory Prostate Cancer (47-02-001)
Brief Summary	The purpose of this research is to determine the effectiveness of CGC-11047 in subjects with metastatic hormone refractory prostate cancer as measured by changes in PSA.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Prostate Cancer
Intervention ^ICMJE	Drug: CGC-11047 CGC-11047 IV weekly for 3 weeks followed by one rest week (4weeks=1cycle)
Study Arm (s)	Experimental: 1 CGC-11047 IV weekly for 3 weeks followed by one rest week (4weeks=1cycle) Intervention: Drug: CGC-11047
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	23
Completion Date	March 2009
Primary Completion Date	November 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Metastatic hormone refractory prostate cancer. Eastern Cooperative Oncology Group (ECOG) Performance status of 0-1. testosterone <50ng/dL. Patients must continue primary androgen deprivation with an LHRH analogue if they have not undergone orchiectomy. Progressive disease after androgen deprivation. Exclusion Criteria: Patients whose clinical condition would make chemotherapy clearly indicated. Patients who have received systemic chemotherapy for the treatment of metastatic disease. Peripheral neuropathy > Grade 1 Prior anti-angiogenic therapy, including thalidomide. Patients with inadequate recovery from any prior surgical procedure, or patients having undergone any major surgical procedure or radiation within 4 weeks prior to study entry. Patients who have received radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment. Patients with known brain metastases or history of brain metastases. History of stroke within 6 months of treatment or other significant neurological limitations. Patients who have received more than 2 prior investigational treatments. Uncontrolled intercurrent illness Patients with a history of a myocardial infarction within the prior 6 months or, hospitalizations for decompensated congestive heart failure within the prior 6 months, or history of significant / symptomatic cardiac arrhythmias
Gender	Male
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00585416
Other Study ID Numbers ^ICMJE	HSC2006-0099, CO06801, 47-02-001
Has Data Monitoring Committee	Yes
Responsible Party	George Wilding, PI for this study at University of Wisconsin, University of Wisconsin
Study Sponsor ^ICMJE	University of Wisconsin, Madison
Collaborators ^ICMJE	Progen Pharmaceuticals
Investigators ^ICMJE	Not Provided
Information Provided By	University of Wisconsin, Madison
Verification Date	April 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top